Companion Diagnostics In Oncologic Development: Idhifa And Lynparza Show Benefit Of Early Focus
Executive Summary
Pink Sheet's Drug Review Profile looks at how Celgene's Idhifa sped from IND to approval, helped by prospective integration of a companion IDH2 mutation diagnostic into the clinical trial, while AstraZeneca's Lynparza was delayed by FDA concerns over retrospective analysis using germline BRCA mutation diagnostic.
You may also be interested in...
US FDA’s Information First Policy: PD-1 Bladder Cancer Alert Aligns With Complementary Diagnostics Perspective
Tecentriq and Keytruda's apparently lower efficacy in low PD-1/L1 patients in ongoing first-line trials prompts communication instead of restriction, underscoring FDA's emerging approach to precision medicine labeling.
Keeping Track: More Rx-To-OTC Switches On Deck After US FDA’s OTC Narcan Approval; Iovance Looks To Bring Cell Therapy To Melanoma
The latest drug development news and highlights form the Pink Sheet’s US FDA Performance Tracker.
Positive Feelings About Negative Controls: US FDA Explores Another Tool For The Real-World Evidence Toolbox
CDC precedents and PDUFA VII commitments could help advance the robustness of observational studies based on real-world data.